Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Not Applicable

Not yet recruiting

• Conditions: Insulin Resistance; Diabetes Mellitus, Type 2; Coronary Artery Bypass Surgery
• Interventions: Dietary Supplement: carbohydrates

• Registration Number: NCT05540249
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Thus, the investigators design a randomized controlled trial investigating the impact of preoperative CHO on postoperative IR and clinical outcomes in diabetic patients undergoing cardiac surgery. The results of the study may give some clinical implications and further improve perioperative care for diabetic patients.

Detailed Description

CHO supplement has been widely investigated in nondiabetic patients undergoing various surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients' well-being in nondiabetic patients. However, whether preoperative CHO could yield similar effects in diabetic patients remains controversial. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and few studies reported IR and postoperative recovery of diabetic patients undergoing cardiac surgery. The investigators present a prospective, single-center, single-blind, randomized, no-treatment controlled trial of preoperative CHO on diabetic patients undergoing off-pump coronary artery bypass grafting (OPCAB). A total of 62 patients will be enrolled and randomized to either Group CHO or Group control (CTRL). Patients in group CHO will receive CHO fluid containing 50 g of carbohydrates the evening before surgery (20:00-24:00) while their counterparts in Group CTRL will be fasted after 20:00 the evening before surgery. The primary endpoints are postoperative insulin resistance (IR) assessed via homeostasis model assessment (HOMA). The secondary endpoints are the potential mediators relating to IR including inflammatory factors and stress reactions assessed by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Previously diagnosed T2DM
2. Diagnosed with CAD with coronary angiography and indicated for OPCAB
3. Age between 18 and 75 years old
4. First operation in the morning and anesthesia induced around 8:00
5. Written informed consent by the patients

Exclusion Criteria

1. Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
2. Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
3. Reduced LVEF (lower than 50%)
4. Combined with gastroesophageal reflux
5. Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
6. Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
7. Refuse to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group CHO	carbohydrates	Patients in Group CHO will orally consume CHO 355ml containing 50 g of carbohydrates 8-12 hours before operation (20:00 -24:00 the evening before operation).

Primary Outcome Measures

Name	Time	Method
Peri-operative Change from baseline HOMA-IR	The fifth morning after surgery	HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

Secondary Outcome Measures

Name	Time	Method
Interleukin -1 (IL-1)	The first morning after surgery	Inflammatory factors
Interleukin-6 (IL-6)	The first morning after surgery	Inflammatory factors
Interleukin-8 (IL-8),	The first morning after surgery	Inflammatory factors
Interleukin-10 (IL-10),	The first morning after surgery	Inflammatory factors
Tumor necrosis fator-α (TNF-α)	The first morning after surgery	Inflammatory factors
High-sensitivity C-reactive protein (hs-CRP)	The first morning after surgery	Inflammatory factors